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Executive Summary

A compromise version of the National Childhood Vaccine Injury Bill (HR 5546) cleared the House Energy & Commerce Committee on Sept. 18 and is expected to move quickly toward House passage with bipartisan support. Introduced by Commerce/Health Subcommittee Chairman Waxman (D-Calif.) earlier this summer ("The Pink Sheet" July 14, p. 9), the bill did not have the support of Rep. Madigan (R-Ill.), the subcommitee's ranking minority member. However, a Waxman/Madigan compromise was fashioned on Sept. 17, shortly before the measure passed the subcommittee. Changes to Waxman's original proposal include stricter liability standards for claims alleging inadequate warnings and deletion of the negligence standard from the litigation section. When introduced as a clean bill, the compromise was cosponsored by 23 congressmen. Merck is said to be fully supportive of the compromise, while Lederle would prefer further amendments. Under the compromise, the bill no longer stipulates that product liability litigation involving vaccine injury must be based on claims of negligence or wrongful conduct. The earlier version provided that claims based on strict liability or a vaccine manufacturer's failure to warn directly about potential risks would be dismissed. Although the new bill allows claims based on failure to warn, it specifies that claims based on manufacturers' failure to warn individuals directly, rather than their physicians, are inadmissible. The measure also provides a rebuttable presumption that a warning meeting FDA requirements constitutes an adequate warning. Other changes include an amendment offered by Rep. Luken (D-Ohio) that requires HHS to submit to Congress "an assessment of the impact of this act on the supply of vaccines." Under the amendment, HHS report are due on June 30, 1987 and every two years thereafter. A referral to the Ways and Means Committee could turn out to be a hurdle for a quick House passage of the bill. The referral was required under House rules due to the manner in which the bill's federal compensation program is funded: initially through a loan from the federal treasury and subsequently through an excise tax placed on routine childhood vaccines. The Reagan Administration reportedly opposes the bill because of the funding provision. The Ways and Means Committee could waive jurisdiction over the bill and allow referral directly to the full House, where it might be considered under suspension of the rules. Another possibility reportedly being considered is incorporating the vaccine bill and Rep. Dingell's (D-Mich.) drug diversion bill in an omnibus drug legislation to be brought directly to the House floor. Sen. Hawkins (R-Fla.) is said to be encouraged by the apparently revived changes for passage of a vaccine injury compensation bill this year. The Labor and Human Resource Committee deleted a provision for a federal compensation program from her bill (S 827). At the time, Hawkins said she thought such a provision would make S 827 unpassable in the Senate but added that she will offer the provision again if the House passes similar legislation ("The Pink Sheet" Aug. 11, p. 10). The Florida Republican's options include amending her measure on the Senate floor and reconsidering S 827 in committee (the legislation is not currently on the agenda of a meeting scheduled for Sept. 24). She has said she does not want the committee-passed bill to go to conference without compensation provisions if House-passed legislation contains them.

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